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Adicet has won Investigational New Drug clearance from the FDA for ADI-001, a chimeric antigen receptor (CAR) gamma delta T-cell therapy for nonHodgkin’s lymphoma. Read More
The FDA on Thursday granted full approval to Gilead Sciences’ Veklury (remdesivir) to treat hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S. Read More
Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring an isocitrate dehydrogenase-1 (IDH1) mutation. Read More
The approval was granted under Project Orbis, which enables concurrent reviews by the FDA and health authorities of Australia, Canada and Singapore. Read More